Vtv Therapeutics Inc. · NASDAQ:VTVT
Vtv Therapeutics — Investor Presentation (February 2019)
29 slides from Vtv Therapeutics's investor presentation, Feb 19, 2019
Slide 1: vTv Therapeutics (VTVT) February 2019
vTv Therapeutics (VTVT) February 2019 NASDAQ: VTVT Exhibit 99.1
Slide 2: Disclosure Notice
Disclosure Notice The statements made in this presentation may include forward-looking statements regarding the Alzheimer’s and diabetes markets, the development and attributes of investigational and marketed products to treat Alzheimer’s disease, diabetes and other conditions, and the future operat
Slide 3: Unwavering Commitment to Science, Patients and Families
Unwavering Commitment to Science, Patients and Families vTv Therapeutics Clinical stage pipeline of novel small molecule drug candidates targeting significant unmet medical needs: Alzheimer’s disease and Diabetes Positive phase 2 results in diabetes with two novel oral candidates Ongoing phase 2 stu
Slide 4: Distinguished Management Team
Distinguished Management Team vTv Therapeutics Steve Holcombe, B.Sc. President, Chief Executive Officer Rudy Howard, B.A., C.P.A. Executive Vice President, Chief Financial Officer Robin Abrams, J.D. Executive Vice President, General Counsel Carmen Valcarce, Ph.D. Executive Vice President, Chief Scie
Slide 5: Robust Pipeline of Novel Product Candidates
Robust Pipeline of Novel Product Candidates vTv Therapeutics PROGRAM PRECLINICAL PHASE 1 PHASE 2 PHASE 3 STATUS MILESTONES Alzheimer’s Disease Azeliragon (TTP488): RAGE Antagonist A-Study completed B-Study stopped at 12 months Planning a study to evaluate the efficacy of azeliragon in patients with
Slide 6: Alzheimer's Disease Program
Alzheimer’s Disease Program
Slide 7: A New Approach to Treating Alzheimer's Disease
A New Approach to Treating Alzheimer’s Disease vTv Therapeutics Azeliragon is an investigational drug being developed for the treatment of AD Born out of 20+ years of groundbreaking research at Columbia University and vTv Azeliragon targets three components of AD pathology by inhibiting RAGE Subgrou
Slide 8: Targeting Three Major Alzheimer's Disease Pathways
Targeting Three Major Alzheimer’s Disease Pathways vTv Therapeutics Azeliragon Mechanism of Action Select ligands bind to RAGE Azeliragon binds to RAGE, blocking ligands from binding to receptor RAGE *Ramasamy R, Shekhtman A, Schmidt AM, The Multiple Faces of RAGE - Opportunities for Therapeutic Int
Slide 9: Dementia: A Complication of Diabetes. Is RAGE the Key?
Dementia: A Complication of Diabetes. Is RAGE the Key? vTv Therapeutics The role of inflammation and RAGE expression/signaling associated with AD and diabetes raises the question of whether RAGE could be a common factor between dementia and diabetes and whether treatment with azeliragon, an oral RAG
Slide 10: HbA1c chosen as a surrogate marker for AGEs: Hypothesis to Identify Potential Subgroup
HbA1c chosen as a surrogate marker for AGEs Hypothesis to Identify Potential Subgroup vTv Therapeutics Findings: “Faster progressors” (Placebo decline 10.5 points/18 months)1 Azeliragon potentially delayed cognitive and functional decline1 Patients with glucose intolerance showed more pronounced res
Slide 11: Analysis of Patients with Diabetes and Baseline Cognitive Deficit
Analysis of Patients with Diabetes (HbA1c ≥ 6.5%) and Baseline Cognitive Deficit (ADAS-cog ≥ 10) Phase 3 Subgroup Results (A-Study): Azeliragon Delayed Decline in Cognition and Function in Subjects with Presumed Increased RAGE Expression Change from Baseline in ADAS-cog11 (mean, SE) A-Study Change f
Slide 12: Subgroup Results: Changes in Biomarker Profile Consistent with RAGE Inhibition
Phase 3 Subgroup Results (A-Study): Changes in Biomarker Profile Consistent with RAGE Inhibition and Target Engagement *nominal p<0.05 Wilcoxon test %Change from Baseline at Month 18 Azeliragon treatment significantly decreased the following markers linked to RAGE: IL6 IL12 INFg CD40L MIP-1 IL2 TNFb
Slide 13: Executive Summary
Executive Summary vTv Therapeutics Mechanism of Action RAGE implicated in both the pathogenesis of AD and diabetic complications Clinical Evidence Results of phase 3 A-Study subgroup analysis in patients with diabetes indicate a potential benefit of treatment with azeliragon Similar effects seen in
Slide 14: Dementia and Diabetes in Numbers
Dementia and Diabetes in Numbers Diabetes(2) Number of People Living with Dementia Number of People ≥65 Living with Diabetes 18M(3) Dementia 50M(1) Diabetes 98M(2) Since the late ‘80s, case-control and prospective epidemiologic studies around the world have reported an association between T2D and de
Slide 15: Literature Supporting Targeting RAGE for Alzheimer's Disease and Diabetes
https://www.ncbi.nlm.nih.gov/pubmed/29368156 https://www.sciencedirect.com/science/article/pii/B9780128094549000093?via%3Dihub Literature Supporting Targeting RAGE for Alzheimer’s Disease and Diabetes https://www.ncbi.nlm.nih.gov/pubmed/26558318 https://journals.plos.org/plosone/article/file?id=10.1
Slide 16: Diabetes Programs Exploring Next-Generation Treatments
Diabetes Programs Exploring Next-Generation Treatments
Slide 17: Diabetes: A Global Health Epidemic
Diabetes: A Global Health Epidemic vTv Therapeutics More than 400 million people were living with diabetes as of 20151 Diabetes remains the 7th leading cause of death in the United States, costing the healthcare system $245 billion annually2 Type 2 diabetes represents 90 percent of people around the
Slide 18: TTP399: A Novel Investigational Therapy to Treat Diabetes
TTP399: A Novel Investigational Therapy to Treat Diabetes vTv Therapeutics TTP399 Liver selective Glucokinase Activator Addressing one of the u nderlying causes of diabetes, Glucokinase: the glucose sensor New MOA complementary to existing treatments Potential therapeutic use in type 1 diabetes (T1D
Slide 19: TTP399-202 Phase 2b Study (AGATA): Sustained Reduction in HbA1c
TTP399-202 Phase 2b Study (AGATA): Sustained, Meaningful Reduction in HbA1c with Well-Tolerated Treatment Regimen in Patients with T2D vTv Therapeutics Secondary Endpoint: Weight Change in HbA1c by Month (%) (N=171) -0.9% **p<0.01 Month Primary Endpoint: HbA1c Well-tolerated: negligible incidences o
Slide 20: TTP399-203 Adaptive Phase 1b/2 Study (Simplici-T1) in Type 1 Diabetes
TTP399-203 Adaptive Phase 1b/2 Study (Simplici-T1): In Collaboration with the JDRF in Type 1 Diabetes (T1D) vTv Therapeutics Results expected in Q1 2020 Phase 1 (Sentinels) Open-label Dose escalation 5 adult patients with T1DM on CSII and CGM Phase 2-Part 1 (Learning Phase) Double-blind Placebo cont
Slide 21: TTP273-201: Oral, Small Molecule GLP-1R Agonist
TTP273-201: Oral, Small Molecule GLP-1R Agonist vTv Therapeutics TTP273 Non-peptide, small molecule, GLP-1r Agonist GLP is a well established and fast growing treatment for type 2 diabetes (T2D) Orally bioavailable – no injection required Favorable tolerability profile – negligible nausea and vomiti
Slide 22: TTP273-201 Phase 2 Study (LOGRA): Results Met Goals
TTP273-201 Phase 2 Study (LOGRA): Results Met Goals vTv Therapeutics Change in Weight at Month 3 (kg) LSmeans placebo-subtracted* (N=142) *p=0.08 compared to placebo * Change in HbA1c by Month (%) LSmeans* (N=142) -0.86% ***p<0.001 Improved Glycemic Control, Weight Loss, Attractive Safety Profile Sa
Slide 23: TTP273-201: Results by Subject Weight Indicate Lower Doses Could Be More Efficacious
TTP273-201: Results by Subject Weight Indicate Lower Doses Could Be More Efficacious vTv Therapeutics Additional Analyses Trends confirmed when correlating TTP273 plasma concentration with efficacy No increase in GI AEs with improved efficacy Trends are not dependent on age, sex, race, duration of d
Slide 24: Partnerships Creating Value with Program Licenses
Partnerships Creating Value with Program Licenses
Slide 25: GLP-1r Program Exclusive License Agreement in China and Other Pacific Rim Territories
In December 2017, vTv granted an exclusive license to Huadong to develop, manufacture and commercialize vTv’s GLP-1r agonist program in China and 15 other regions in the Pacific Rim excluding Japan Huadong will develop the GLP-1r program for type 2 diabetes in its territory vTv is eligible to receiv
Slide 26: PDE4 Inhibitor Program: Licensed Limited Territory Rights
PDE4 Inhibitor Program: Licensed Limited Territory Rights vTv Therapeutics COPD Market in China 8.6% (~100 million) COPD patients in China1 Annual sales of top 2 products (Seretide and Spiriva) greater than $132M USD Total COPD market at $4.5B USD Newsoara was established in 2018 to in-license innov
Slide 27: PPAR-d Agonist Program: Licensed Worldwide Rights
PPAR-d Agonist Program: Licensed Worldwide Rights vTv Therapeutics In December 2017, vTv granted an exclusive worldwide license to Reneo to develop, manufacture and commercialize vTv’s PPAR-d program Reneo will develop the program in orphan diseases associated with deficits in cellular metabolism an
Slide 28: vTv Therapeutics Financial Snapshot
vTv Therapeutics (share data as of 1/31/2018) NASDAQ Capital Market (Ticker: VTVT) Market cap: $129.4 million Shares outstanding: 45.1 million Stock price: $2.87 Stock Information Q3 2018 Financial Information (in thousands) Cash $3,766 Debt $18,208 MacAndrews Equity Commitment (as of 2/14/2019) Dat
Slide 29: Discovering and Developing Innovative Therapies for Substantial Markets
Discovering and Developing Innovative Therapies for Substantial Markets vTv Therapeutics vTv is a small and nimble company that has integrated innovative science with clinical drug discovery in challenging areas like Alzheimer’s disease and Diabetes vTv has a novel pipeline of programs including its
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