Vivoryon Therapeutics N.v. · EURONEXT:VVY
Vivoryon Therapeutics — FY2023 Earnings Presentation
24 slides from Vivoryon Therapeutics's earnings presentation, Apr 24, 2024
Slide 1: Full Year 2023 Results & Strategic Update
Full Year 2023 Results & Strategic Update Webcast and Conference Call April 24, 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 INTRODUCTION 02 VAROGLUTAMSTAT IN ALZHEIMER’S DISEASE VAROGLUTAMSTAT IN KIDNEY / FIBROTIC & AGENDA 03 INFLAMMATORY DISEASE 04 2023 FINANCIALS 05 OUTLOOK & STRATEGIC PRIORITIES 06 Q&A
Slide 4: Prioritizing resources to maximize value from varoglutamstat & pipeline following negative topline results
Prioritizing resources to maximize value from varoglutamstat & pipeline following negative topline results from VIVIAD study in early AD Shift in strategic focus towards inflammatory 2024 – Significant post-period events and fibrotic disorders, from AD ◆ VIVIAD in early AD – topline data reported in
Slide 5: Detailed VIVIAD analysis suggests no consistent effect in early AD, but significant effect on kidney function
Detailed VIVIAD analysis suggests no consistent effect of varoglutamstat up to 600mg BID in early AD, but a significant effect on kidney function at 600mg BID ◆ No statistical effect of varoglutamstat up to 600mg ◆ Statistically significant improvement of kidney eGFR BID on primary or secondary endp
Slide 6: Varoglutamstat in Alzheimer's Disease (AD)
VAROGLUTAMSTAT IN ALZHEIMER’S DISEASE (AD) VIVIAD PHASE 2B – INITIAL DATASETS
Slide 7: VIVIAD did not demonstrate a statistically significant change in cognition
VIVIAD did not demonstrate a statistically significant change in cognition with varoglutamstat up to 600mg BID compared to placebo Primary Endpoint: Cogstate 3-item Secondary Endpoint: Cogstate Brief Battery Secondary Endpoint: Cogstate NTB Slope analysis1 Slope analysis1 Slope analysis1 Baseline th
Slide 8: No significant effect on activities of daily living and EEG theta power
VIVIAD did not demonstrate a statistically significant effect on activities of daily living and EEG theta power of varoglutamstat up to 600mg BID A-IADL-Q Scores EEG Global Relative Theta Power (4-8 Hz) Change from Baseline at week 48 Change from Baseline at week 48 0 0.02 Estimated Difference from
Slide 9: No consistent effect on most pre-specified and exploratory AD endpoints
VIVIAD analysis reveals no consistent effect of varoglutamstat at 300mg and 600mg BID on most pre-specified and exploratory AD endpoints Pre-specified subgroup analysis Exploratory endpoints ◆ No clinically meaningful and no statistically ◆ No clinically meaningful and no statistically significant d
Slide 10: Drug concentration and QPCT/L inhibition match previously published results
Drug concentration and QPCT/L (QC) inhibition measured in VIVIAD match previously published results Varoglutamstat concentrations measured in CSF Target Occupancy (TO) in CSF D o s e -R e s p o n s e (T a r g e t o c c u p a n c y in C S F ) 100 93.4 D a ta a n d M o d e l median 8 3 .3 fro m P h a
Slide 11: VIVIAD key safety data show varoglutamstat is well tolerated
VIVIAD key safety data show varoglutamstat up to 600mg BID is well tolerated Varoglutamstat Placebo Total Item N (%)1 N (%)1 N (%)1 Patients randomized 142 117 259 Subjects who completed treatment 119 (83.8) 105 (89.7) 224 (86.5) Subjects discontinued from treatment 23 (16.2) 12 (10.3) 35 (13.5) - d
Slide 12: VIVIAD data to inform future development at higher doses in early AD
VIVIAD data to inform future potential development of varoglutamstat in early AD at higher doses VIVIAD key learnings early AD Looking ahead in early AD ◆ Dose of varoglutamstat up to 600mg BID ◆ Discontinue VIVA-MIND study in H2 2024; not effective in treatment of early AD initial results with varo
Slide 13: Varoglutamstat Effect on Kidney Function
UPDATE VAROGLUTAMSTAT EFFECT ON KIDNEY FUNCTION INITIAL DATA FROM VIVIAD
Slide 14: VIVIAD exploratory kidney function endpoint founded in scientific rationale
VIVIAD exploratory endpoint analyzing kidney function founded in scientific rationale Varoglutamstat: Modulation of fibrotic and inflammatory processes on multiple layers ◆ Many kidney diseases are driven by inflammatory and fibrotic processes induced by a variety of stimuli including metabolic, vas
Slide 15: eGFR slope analysis shows significant improvement for varoglutamstat 600mg BID
eGFR slope analysis across 96 weeks in VIVIAD show statistically significant and clinically meaningful improvement for varoglutamstat 600mg BID Total Population n=258 Dose Response Total population 3.00 Dose Response 2.65 2.50 2.50 eGFR annualized rate of change eGFR annualized rate of change 1.92 2
Slide 16: Significant effect in patients with risk factors for CKD
Varoglutamstat shows a statistically significant and clinically meaningful effect in patients with risk factors for CKD defined as type 2 diabetes or hypertension Dose Response, Risk Factors YES Dose Response, Risk Factors NO 5.00 5 3.91 eGFR annualised rate of change eGFR annualised rate of change
Slide 17: Encouraging kidney function data shapes development path and strategic priorities
Encouraging VIVIAD kidney function data shapes development path in kidney disease and strategic priorities for varoglutamstat VIVIAD key learnings kidney disease Looking ahead in kidney disease ◆ Statistically significant and clinically ◆ Conduct additional biomarker analysis meaningful improvement
Slide 18: Financial Results
FINANCIAL RESULTS
Slide 19: Condensed statement of profit and loss
Condensed statement of profit and loss In €k Dec 31, 2023 Dec 31, 2022 YoY in % Revenue (3,620)* - - Research and development expenses (17,637) (20,224) (13) % General and administrative expenses (8,600) (8,908) (3) % Operating loss (28,837) (29,113) (1) % Finance result 261 758 Income taxes 234 199
Slide 20: Key financial figures
Key financial figures In €k Dec 31, 2023 Dec 31, 2022 Cash and cash equivalents 18,562* 26,555 Total assets 30,829 31,378 Total equity 26,282 26,506 In €k Dec 31, 2023 Dec 31, 2022 Cash flows used in operating activities (21,541) (21,794) Cash flows used in investing activities (10,514)* (13) Cash f
Slide 21: Outlook & Strategic Priorities
OUTLOOK & STRATEGIC PRIORITIES
Slide 22: Outlook - Shift R&D focus towards inflammatory and fibrotic disorders
Outlook - Shift research & development focus towards inflammatory and fibrotic disorders such as kidney disease Exciting potential opportunity for Assess feasibility of higher dose varoglutamstat in kidney disease varoglutamstat in early AD ◆ Leverage very promising VIVIAD data to further ◆ Fully an
Slide 23: Q&A
Q&A
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 Info@vivoryon.com +49 (0)345 555 99 00 www.vivoryon.com