Vivoryon Therapeutics N.v. · EURONEXT:VVY
Vivoryon Therapeutics — Q1 2024 Earnings Presentation
26 slides from Vivoryon Therapeutics's earnings presentation, May 23, 2024
Slide 1: Q1 Financial Results Webcast and Conference Call
Q1 Financial Results Webcast and Conference Call May 23, 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: Agenda
01 OVERVIEW 02 VAROGLUTAMSTAT IN KIDNEY DISEASE AGENDA 03 FINANCIAL RESULTS 04 OUTLOOK & STRATEGIC PRIORITIES 05 Q&A
Slide 4: Recent findings confirm strong kidney function data
Recent findings confirm strong kidney function data and reinforce our strategic shift towards inflammatory and fibrotic diseases Q1 and post-period highlights Recent findings / activities2 ◆ VIVIAD kidney analysis – revealed statistically ◆ Analysis continues to confirm strong kidney significant eff
Slide 5: Varoglutamstat in Kidney Disease
VAROGLUTAMSTAT IN KIDNEY DISEASE
Slide 6: QPCT/L inhibitors and inflammation/fibrosis: Over a decade of research and know-how
QPCT/L inhibitors and inflammation/fibrosis: Over a decade of research and know-how Persistent low-grade inflammation is now considered a hallmark feature of chronic kidney disease (CKD)1 ◆ Many inflammatory and fibrotic pathways require formation of N-terminal pyro-glutamates (pE) for full activity
Slide 7: QPCT/L inhibition with PQ529 shows reduction of inflammatory cytokines
QPCT/L inhibition with PQ529 shows reduction of inflammatory cytokines and improvement of kidney function in a rat glomerulonephritis model inflammatory signal reduced Dose-dependent suppression in pE-CCL2 levels ◆ Following 3 weeks of repeated administration of PQ529 (30 and 100 mg/kg) Kidney funct
Slide 8: VIVIAD exploratory endpoint analyzing kidney function founded in scientific rationale
VIVIAD exploratory endpoint analyzing kidney function founded in scientific rationale Varoglutamstat: Modulation of fibrotic and inflammatory processes on multiple layers ◆ Based on the known anti-inflammatory activity of varoglutamstat, VIVIAD protocol included investigation of kidney function and
Slide 9: Significant reduction in pE-CCL2 levels in VIVIAD patients
Varoglutamstat’s potential role in modifying inflammatory pathways demonstrated by significant reduction in pE-CCL2 levels in VIVIAD patients Change from baseline in serum pE-CCL2 levels at week 48 ◆ Analysis of serum samples from VIVIAD study showed statistically significant dose- dependent decreas
Slide 10: Statistically significant improvement in kidney function
Statistically significant and clinically meaningful improvement in kidney function measured by eGFR (slope analysis; total VIVIAD population) Sustained improvement in estimated glomerular filtration rate (eGFR) – a primary endpoint in many development programs of kidney disorders Total change Annual
Slide 11: Improvement in eGFR consistent between MDRD and CKD-EPI 2021
Improvement in eGFR was consistent between MDRD and CKD-EPI 2021 calculations for eGFR (slope analysis) MDRD method CKD-EPI 2021 (Creatinine) method Total population Total population 2.5 2 eGFR annualized rate of change 1.92 eGFR annualized rate of change 2.0 1.44 1.5 mL/min/1.73m^2/year 1.5 mL/min/
Slide 12: Consistency of results and effect size using diverse methods
Consistency of results and effect size using a set of 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- 2021 CKD-EPI creatinine MDRD cystatin C * ***
Slide 13: Effect in patients with risk factors for CKD
Statistically significant and clinically meaningful effect in patients with risk factors for CKD defined as type 2 diabetes or hypertension Varoglutamstat effect on eGFR in patients with risk factors Dose Annualized Response, change Risk in in eGFR (MDRD) Factors subjectsYES with risk factors Change
Slide 14: Effect across eGFR impairment levels at baseline
Effect of varoglutamstat on eGFR was also consistent across eGFR impairment level at baseline Varoglutamstat annualized change of eGFR versus placebo 5 4 varoglutamstat vs. placebo mL/min/1.73m2/year Annualized eGFR 3 2 1 0 eGFR 30-59 ml/min eGFR 60-89 ml/min eGFR >= 90 ml/min n = 16 n = 179 n = 64
Slide 15: Robust proof-of-concept data supports further evaluation in kidney disease
Robust proof-of-concept data demonstrating improvement of kidney function with QPCT/L inhibitors supports further evaluation of varoglutamstat in kidney disease Study Biomarker Kidney Function Safety Pre-clinical data Rat Animal Model1 - Dose-dependent Dose-dependent Good safety profile with PQ529 r
Slide 16: Addressing kidney disease is a rising global health imperative
Addressing kidney disease is a rising global health imperative with high unmet needs High prevalence − Deadly Increasing mortality Global prevalence increasing, driven by a growing and ageing population and increase in diabetes, heart disease 3rd fastest-growing cause of death 3 5th highest cause of
Slide 17: Varoglutamstat potential in large indications – CKD
Varoglutamstat potential in large indications – e.g. chronic kidney disease (CKD) CKD is marked by a slow progressive decline in There remains a high unmet need for new treatment kidney function, often leading to kidney failure options for patients Persistent albuminuria categories Description and r
Slide 18: Varoglutamstat potential in orphan diseases – Alport Syndrome
Varoglutamstat potential in orphan diseases – e.g. Alport Syndrome Progressive decline in There remains a high unmet need for new treatment mutations in collagen IV genes kidney function leading options for people with Alport Syndrome to failure Caused by x-linked genetic Need ◆ No specific treatmen
Slide 19: Varoglutamstat has the potential to be the first QPCT/L inhibitor
Varoglutamstat has the potential to be the first QPCT/L inhibitor to improve kidney function in people with kidney disorders Broad potential opportunity in CKD, First-in-class orphan kidney diseases and other inflammatory QPCT/L inhibitor and fibrotic diseases Promising PoC data Full rights in Follo
Slide 20: VIVIAD kidney function data informs priorities for varoglutamstat
VIVIAD kidney function data informs priorities for varoglutamstat in 2024 and beyond, shaping clinical development path decisions and goals in kidney disease Status Next Step Compelling evidence achieved Decide clinical path / indications ✓ Statistically significant Main clinical development goals S
Slide 21: Financial Results
FINANCIAL RESULTS
Slide 22: Key financial figures
Key financial figures In €k Mar 31, 2024 Mar 31, 2023 Revenue 0 0 Research & Development expenses (7,425) (3,104) General & Administrative expenses (2,084) (1,906) Net loss for the period (9,329) (5,110) In €k Mar 31, 2024 Dec 31, 2023 Cash & cash equivalents 21,994 18,562* Financial assets 0 10,165
Slide 23: Outlook & Strategic Priorities
OUTLOOK & STRATEGIC PRIORITIES
Slide 24: Strong kidney data reinforce strategic shift
Strong kidney data reinforce strategic shift to inflammation and fibrosis-driven kidney indications and are a further step towards securing Company’s future Pursue actionable plan to establish Complete Phase 2 AD program, presence in kidney disease explore select early stage programs ◆ Rigorous scie
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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