Vivoryon Therapeutics N.v. · EURONEXT:VVY
Vivoryon Therapeutics — H1 2023 Earnings Presentation
15 slides from Vivoryon Therapeutics's earnings presentation, Sep 7, 2023
Slide 1: First Half 2023 Results Webcast and Conference Call
FIRST HALF 2023 RESULTS WEBCAST AND CONFERENCE CALL September 7, 2023 |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: Advancing a Uniquely Differentiated Small Molecule Medicine to Treat Alzheimer's Disease
Vivoryon: Advancing a Uniquely Differentiated Potential Best-/First- in-Class Small Molecule Medicine to Treat Alzheimer’s Disease Unique first-in-class Phase 2 studies progressing well Senior management changes and approach designed to with no drug-related ARIA, very low funding support future succ
Slide 4: Experienced Leadership
Experienced Leadership Strengthened Management and Board Bring Key Drug Development Experience and Business Acumen MANAGEMENT NON-EXECUTIVE DIRECTORS Frank Weber, MD Erich Platzer, MD, PhD Chief Executive Officer/Chief Medical Officer Chairman of the Board Kugan Sathiyanandarajah Vice-Chairman & Cha
Slide 5: Highlights H1 2023 and Post-Period
Highlights H1 2023 and Post-Period ◆ VIVIAD Phase 2b: Independent DSMB decision to continue without modification; on track for final data readout in Q1/2024 Progressing Trials ◆ VIVA-MIND Phase 2a/b: Completed recruitment of Cohort A (60 patients, 600mg bid); study actively recruiting participants i
Slide 6: Varoglutamstat: Rigorous Clinical Development Strategy
Varoglutamstat: Rigorous Clinical Development Strategy Carefully crafted strategy towards well-designed and well-powered placebo-controlled Phase 2b studies Pivotal study or Phase 2b VIVIAD Assessment of safety, tolerability and accelerated approval efficacy in 250 patients with MCI or § FDA Fast Tr
Slide 7: Phase 2a SAPHIR Study: Evidence of Significant Changes in Working Memory and Synaptic Recovery
Phase 2a SAPHIR Study: Evidence of Significant Changes in Working Memory and Synaptic Recovery After Only 12w Treatment Significant Changes in Recovery EEG Reduction of Working Memory1 Synaptic Activity1,2 Neuronal Injury Biomarker1 P=0.05 Placebo Varoglutamstat Alpha wave neuronal connectivity Thet
Slide 8: VIVIAD: Study Design to Enable Precision Recruitment
VIVIAD: Study Design to Enable Precision Recruitment Lessons learned: Recruiting the right patients with early AD is a critical success factor for VIVIAD BASIC REQUIREMENT: ◆ Mandatory sampling for inclusion: all patients included had low Abeta and high p-tau CSF values RETHINKING MCI ASSESSMENT: ◆
Slide 9: VIVIAD: Low Number of Discontinuations Due to AE
VIVIAD: Low Number of Discontinuations Due to AE SAPHIR (active and placebo groups) vs. blinded VIVIAD data 18 Safety profile of varoglutamstat 16 strongly improved vs. 1st in 14 patient study SAPHIR 12 ◆ Total number of discontinuations discontinuing Discontinuations due to % patients 10 AE (safety
Slide 10: Condensed Statement of Profit and Loss
Condensed Statement of Profit and Loss In €k June 30, 2023 June 30, 2022 YoY in % Research and development expenses (6,259) (11,067) -43 % General and administrative expenses (4,433) (2,311) 92 % Operating loss (10,692) (13,378) -20 % Finance result (69) 884 Income taxes 45 (89) Net loss for period
Slide 11: Key Financial Figures
Key Financial Figures In €k June 30, 2023 December 31, 2022 Cash and cash equivalents 29,582* 26,555 Total assets 45,355 31,378 Total equity 41,534 26,506 Shares (number) 25,961,892 24,105,278 In €k June 30, 2023 June 30, 2022 Cash flows used in operating activities (20,283)* (10,237) Cash flows use
Slide 12: Multiple Value-Generating Catalysts and Events Ahead
Multiple Value-Generating Catalysts and Events Ahead Upcoming ◆ R&D Day with KOLs1 in Q4/2023 on varoglutamstat, scientific approach and study design Events ◆ Multiple investor interactions throughout Q4/2023 to update on progress Clinical ◆ VIVA-MIND U.S. Phase 2a/b status update Q4/2023 Progress ◆
Slide 13: Varoglutamstat Positioned for Continued Value Generation
Varoglutamstat Positioned for Continued Value Generation Differentiated Phase 2 Asset with Unique Potential in AD ◆ N3pE-Abeta is a validated target in AD; reducing pE concentration has shown to reduce progression of cognitive decline in early AD1,2 ◆ Glutaminylcyclase QPCT is required for N3pE-Abet
Slide 14: Q&A
Q&A
Slide 15: 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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