Vivoryon Therapeutics N.v. · EURONEXT:VVY
Vivoryon Therapeutics — Investor Presentation (October 2023)
18 slides from Vivoryon Therapeutics's investor presentation, October 2023
Slide 1: Upstream intervention to address multiple hallmarks of AD
Upstream intervention to address multiple hallmarks of AD Tackling AD at the roots |Vivoryon Therapeutics N.V. – October 2023
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: Vivoryon Uniquely Positioned to Bring Oral, Highly Differentiated, Post PoC Small Molecule to Patients
Vivoryon Uniquely Positioned to Bring Oral, Highly Differentiated, Post PoC Small Molecule to Patients with Alzheimer’s Disease Unique first-in-class approach designed Phase 2 studies progressing well with no Senior management changes and to overcome challenges in AD drug-related ARIA, very low AE-r
Slide 4: Recent Management and Board Changes Strengthen Development Experience
Recent Management and Board Changes Strengthen Development Experience, Enhance Business Acumen and Prepare Company for Next Phase MANAGEMENT NON-EXECUTIVE DIRECTORS Frank Weber, MD Erich Platzer, MD, PhD Chief Executive Officer/Chief Medical Officer Chairman of the Board Kugan Sathiyanandarajah Vice
Slide 5: Vivoryon Pioneering Small Molecule-Based Therapies Designed to Prevent N3pE-Abeta Formation
Vivoryon Pioneering Small Molecule-Based Therapies Designed to Prevent N3pE-Abeta Formation Rather Than Aiming to Clear Existing Plaques ONGOING CHALLENGES IN AD VIVORYON’S APPROACH Discovered QPCT-mediated formation of a ~30 million people worldwide and expected to double by 2050, with neurotoxic A
Slide 6: Our Lead Product Candidate, Varoglutamstat, Targets Multiple Key Hallmarks of Alzheimer's Disease
Our Lead Product Candidate, Varoglutamstat, Targets Multiple Key Hallmarks of Alzheimer’s Disease Early in Pathological Process ROLE OF QPCT/L IN AD PATHOLOGY VAROGLUTAMSTAT TARGETS AD PATHOGENESIS EARLY-ON Increased activity of glutaminyl cyclase (QPCT) is Abeta CCL2 associated with AD pathology in
Slide 7: QPCT/L Inhibition Has Significant Potential in Humans with Alzheimer's Disease
QPCT/L Inhibition Has Significant Potential in Humans with Alzheimer’s Disease: Translating In Vivo Evidence into Proof of Concept in AD Patients Abeta Pathology QPCT is essential for N3pE amyloid formation in vivo1 Dose-dependent reduction of QPCT 5XFAD mice, QPCT ko and tg QPCT/ N3pE activity in C
Slide 8: Varoglutamstat Clinical Development Strategy
Varoglutamstat Clinical Development Strategy Clear Path To Potential Regulatory Approval Based on Well-Informed, Extensive Phase 1 and Phase 2 Trials Pivotal study or Phase 2b VIVIAD accelerated approval Assessment of safety, tolerability and efficacy in 250 patients with MCI or FDA Fast Track desig
Slide 9: Phase 2a SAPHIR Study Provides Evidence of Significant Changes in Working Memory and Synaptic Recovery
Phase 2a SAPHIR Study Provides Evidence of Significant Changes in Working Memory and Synaptic Recovery After Only 12 Weeks of Treatment Significant Changes in Recovery EEG Reduction of Working Memory1 Synaptic Activity1,2 Neuronal Injury Biomarker1 P=0.05 Placebo Varoglutamstat Alpha wave neuronal c
Slide 10: VIVIAD Assesses Safety, Tolerability and Efficacy of Varoglutamstat in Patients with MCI and Mild AD
VIVIAD Assesses Safety, Tolerability and Efficacy of Varoglutamstat in Patients with MCI and Mild AD1,2 Site visits 4 12 16 24 INTERIM SAFETY 36 48 60 72 84-96 FINAL DATA Mid-22 1Q24 w 13-24 FIRST 90 PATIENTS 1:1:1 w 25–48/96 Placebo / 300 mg / 600 mg DSMB DECISION ALL PATIENTS Safety / Final dose (
Slide 11: VIVIAD Inclusion Criteria Enabled Precision Recruitment
VIVIAD Inclusion Criteria Enabled 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 12: 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 13: Informed Design of VIVIAD vs. SAPHIR: Slower Titration and Lower Final Dose
Informed Design of VIVIAD vs. SAPHIR: Slower Titration and Lower Final Dose While Maintaining Level of Target Inhibition Weeks 1 2 3&4 5 to 8 9 to 12 After 12 Dose and titration varoglutamstat mg SAPHIR 400 BID 800 BID 800 BID 800 BID 800 BID STOP VIVIAD 50 OD 50 OD 50 BID 150 BID 300 BID 600 BID %
Slide 14: VIVA-MIND Recruiting into Cohort B and Has Option to Transform into Confirmatory Phase 3
VIVA-MIND Recruiting into Cohort B and Has Option to Transform into Confirmatory Phase 3 START Site visits 4 8 12 16 24 36 48 60 72 2H21 w 1-24 PHASE 2 PHASE 2 ADAPTIVE DOSE FINDING ONGOING w 25 – 72 TREATMENT 180 patients 180 patients ENDPOINTS Placebo / 600 mg / 300 mg / 150 mg Placebo / selected
Slide 15: Vivoryon's Pipeline Focused on Alzheimer's Disease with Potential Follow-on Programs
Vivoryon’s Pipeline Focused on Alzheimer’s Disease with Potential Follow-on Programs Program Approach Discovery Preclinical Phase 1 Phase 2a Phase 2b Phase 3 Status Varoglutamstat SMI (PQ912) VIVIAD - Ph2b in EU Fully recruited; Final readout Q1/2024 QPCT/L Varoglutamstat SMI Ph 2a ongoing; expanded
Slide 16: 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 17: 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 18: Vivoryon Therapeutics N.V. contact details
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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