Vtv Therapeutics Inc. · NASDAQ:VTVT
Vtv Therapeutics — Investor Presentation (August 2020)
26 slides from Vtv Therapeutics's investor presentation, August 2020
Slide 1: Corporate Presentation
Corporate Presentation First-in-class molecules for organ protection in metabolic diseases August 2020
Slide 2: Forward looking statements
Forward looking statements The statements made in this presentation may include forward-looking including our most recent 2019 Annual Report on Form 10-K. statements regarding the type 1 diabetes, Alzheimer’s disease, cystic Undue reliance should not be placed on forward-looking statements, fibrosis
Slide 3: Company Overview: Our Focus
Company Overview Our Focus We are focused on treating metabolic diseases to minimize their long-term complications through end-organ protection Our innovative pipeline of first-in-class small molecules, emphasis on clinical trial execution, and long-term sponsor support are the keys to our success.
Slide 4: Our People
Company Overview Our People Jeff Kindler, JD Steve Holcombe, B Sc Carmen Valcarce, PhD Rudy Howard, BA CPA Aaron Burstein, PharmD Chairman of the Board President, CEO Executive Vice President, CSO Executive Vice President, CFO Senior Vice President, Clinical Development CEO, Centrexion Therapeutics
Slide 5: Pipeline
Company Overview Pipeline Indication Preclinical Phase I Phase II Phase III Biological Rational TTP399 (GKA) Liver-selective GKA; no disruption of GK Type 1 Diabetes (T1D) regulatory protein Dementia with Diabetes Azeliragon (RAGE) Small molecule antagonist of RAGE Cystic Fibrosis Related TTP273 (Or
Slide 6: Diabetes: TTP399
Diabetes TTP399 Liver-Selective Glucokinase Activator (GKA) as an Adjunctive Treatment to Insulin in T1D
Slide 7: T1D is a Burdensome Disease
Type 1 Diabetes / TTP399 T1D is a Burdensome Disease Risk of day time People with T1D never get a hypoglycemia It requires constant day off from managing it management, 24 hours a day It requires constant monitoring Must count the carbs and of blood glucose levels account for everything they eat Peo
Slide 8: Insulin Alone is Not Enough
Type 1 Diabetes / TTP399 Insulin Alone is Not Enough Nearly 80% of people with type 1 diabetes Life-threatening, short-term fail to achieve ADA target A1c levels1 complications of poor glycemic control Despite improved and more widely adopted diabetes technology, clinical outcomes continue to declin
Slide 9: Limited Treatment Options for a Significant Patient Population
Type 1 Diabetes / TTP399 Limited Treatment Options for a Significant Patient Population Large commercial opportunity with No approved oral therapies for T1D in the US, and available T2D treatments significant unmet need have limited potential in T1D(4) ▪ 30 million people suffer from T1D globally(1)
Slide 10: GKA, a Unique Biological Strategy to Support T1D Patients
Type 1 Diabetes / TTP399 GKA, a Unique Biological Strategy to Support T1D Patients Glucokinase facilitates a critical step in sugar metabolism TTP399: A liver selective Glucokinase Activator1 Glucokinase is the glucose sensor of the body Key role in glucose homeostasis supported by strong genetic ev
Slide 11: Simplici-T1 — Adaptive Phase 1b/2 Study Trial Design
Type 1 Diabetes / TTP399 Simplici-T1 — Adaptive Phase 1b/2 Study Trial Design 2019 2020 Study Details: • Double-blind Placebo controlled Phase 2-Part 1 Phase 2-Part 2 • The Simplici-T1 trial was designed to (Learning Phase) (Confirming Phase) –Designed to confirm explore the safety and efficacy of t
Slide 12: Simplici-T1 Study - Key Results
Type 1 Diabetes / TTP399 Simplici-T1 Study - Key Results ▪ Statistically significant reduction in HbA1c under a treat-to-target design (i.e. compared to intensive insulin treatment) ▪ Reduced total daily mealtime bolus insulin relative to baseline ▪ No report of diabetic ketoacidosis, trends towards
Slide 13: Phase 2 Study Met Primary Endpoint, Reduced HbA1c
Type 1 Diabetes / TTP399 Phase 2 – Study (Parts 1 and 2 ) Met Primary Endpoint, Reduced HbA1c Statistically Significant HbA1c Reductions Without Increases in Ketones or Hypoglycemia Part 1 Part 2 Baseline Mean HbA1c: 7.3% Baseline Mean HbA1c: 7.6% Change from Baseline in HbA1c (%) 0.20 0.1 Change fr
Slide 14: Part 2: Better Glycemic Control while Reducing Insulin Dose
Type 1 Diabetes / TTP399 Phase 2 - Part 2: TTP399 Treated Subjects Achieved Better Glycemic Control while Reducing Insulin Dose Δ HbA1c vs ΔTOTAL Insulin Change in HbA1c @ W12 by Subgroup Decreased Stable Increased Insulin Insulin Insulin 0.6 0.23% 0.4 LSmeans Change in A1c (%) 0.2 n=13 n=13 n=11 n=
Slide 15: Phase 2 – Part 2 Safety
Type 1 Diabetes / TTP399 Phase 2 - Part 2: Compelling Safety Profile with No Diabetic Ketoacidosis and No Incidence of Severe Hypoglycemia in the TTP399 Group Phase 2 – Part 2 Safety: ▪ No diabetic ketoacidosis ▪ No incidence of severe hypoglycemia in TTP399 group (1 incident in placebo group) ▪ Fe
Slide 16: Development Plan
Type 1 Diabetes / TTP399 Development Plan* Requested and received Type C Meeting feedback from FDA – dialogue Ongoing continuing Initiate 6 month pivotal trial followed by 6 mo Open Label Extension End of 2020 ➢Exploring primary endpoints of reduced HbA1c and/or reduced hypoglycemia or DKA End of 20
Slide 17: Dementia: Azeliragon
Dementia Azeliragon RAGE antagonist for Dementia with Diabetes
Slide 18: The Significance of Dementia with Diabetes
Brain / Azeliragon (RAGE) The Significance of Dementia with Diabetes Prevalence of Dementia (Alzheimer’s) with Diabetes Market Size Market for Dementia with 2017 2030 diabetes expected to reach $2.04B by 2030 in 7MM* 3.09M from $1.18B in 2017 2.14M 3.86M* 5.64M* *7 Major Markets: US, Germany, France
Slide 19: Targeting RAGE for Treatment of Dementia with Diabetes
Brain / Azeliragon (RAGE) Targeting RAGE for Treatment of Dementia with Diabetes Azeliragon antagonizes the Receptor for Advanced Well established associations between AGEs / RAGE Glycation Endproducts (RAGE), blocking ligands from and diabetic complications binding to the receptor and blunting resu
Slide 20: Potential Beneficial Effect on Cognition in Patients with Elevated HbA1c
Dementia with Diabetes / Azeliragon (RAGE) Potential Beneficial Effect on Cognition in Patients with Elevated HbA1c STEADFAST A-Study All Subjects (FAS) STEADFAST A-Study Type 2 Diabetes Subgroup (FAS) ADAS-cog11 ADAS-cog11 - 3 -3 - 2 -2 e n t -1 Im p ro v e m e n t - 1 p r o v e m B a s e lin e C h
Slide 21: Brain MRI, FDG-PET and Plasma Biomarker Results
Dementia with Diabetes / Azeliragon (RAGE) Brain MRI, FDG-PET and Plasma Inflammatory Biomarker Results Support Biological Effect in Dementia with Diabetes STEADFAST A-Study Type 2 Diabetes Subgroup (FAS) Less Brain Atrophy Less Reduction in Brain Reduction in Plasma Inflammatory Biomarkers Whole Br
Slide 22: Elevage Study: Two Studies Under a Single Protocol
Dementia with Diabetes / Azeliragon (RAGE) Elevage Study: Two Studies Conducted Under a Single Protocol 2021 2022 STARTED JUNE 2019 2H 2021 Phase 2 Phase 3 (Part 1 / Proof of Concept) – 6 months, targeting ~50 patients to (Design pending) be enrolled by end of Q3 2020 Demonstrate safety and efficacy
Slide 23: Development Plan
Dementia / Azeliragon (RAGE) Development Plan NDA enabling studies are complete, positioning azeliragon for an NDA submission upon successful, positive clinical trials 2Q 2021 Seek FDA guidance 2H 2021 Elevage Phase 2 Prior to Initiating Initiate Top-line Results Registration Trial Registration Tria
Slide 24: Partnered Development Programs
Partnered Development Programs
Slide 25: Creating Value Through Partnerships
Development Programs Creating Value Through Partnerships Asset Partner Territory Target Indications Economics for vTv HPP737 (PDE4i) China and other Pacific COPD Milestones and royalties Rim Countries (excl. Utilization of data to advance development in ROW Japan) PPAR-𝛿 Worldwide Primary…
Slide 26: Thank you
Thank you
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