Vtv Therapeutics Inc. · NASDAQ:VTVT
Vtv Therapeutics — Investor Presentation (January 2025)
30 slides from Vtv Therapeutics's investor presentation, Jan 13, 2025
Slide 1: Improving the Lives of Millions of People Living with Type 1 Diabetes
1 Nasdaq: VTVT Improving the Lives of Millions of People Living with Type 1 Diabetes January 2025
Slide 2: Forward-Looking Statements
2 THE STATEMENTS MADE IN THIS PRESENTATION AND THE ACCOMPANYING ORAL COMMENTARY MAY INCLUDE FORWARD-LOOKING STATEMENTS REGARDING (I) THE DIABETES MARKET AND OTHER MARKETS, (II) THE DEVELOPMENT, CLINICAL TRIAL PROCESS, REGULATORY APPROVAL PROCESS AND ATTRIBUTES OF INVESTIGATIONAL AND MARKETED PRODUCT
Slide 3: Pioneering Oral Drugs for Challenging Targets to Help Treat Diverse Chronic Diseases
3 Pioneering Oral Drugs for Challenging Targets to Help Treat Diverse Chronic Diseases Advancing late-stage cadisegliatin program for type 1 diabetes Partnerships for potential additional upside and shareholder value
Slide 4: Experienced Leadership with Decades of Life Sciences Expertise
4 Experienced Leadership with Decades of Life Sciences Expertise Martin Lafontaine Chief Commercial Officer Thomas Strack, MD Chief Medical Officer Steven Tuch Chief Financial Officer Rich Nelson Chief Business Officer Paul Sekhri Chair, President & CEO Carmen Valcarce, PhD Chief Scientific Officer
Slide 5: Cadisegliatin: Late-Stage Clinical Development
5 Cadisegliatin: Late-Stage Clinical Development Product Indication Pre-clinical Phase I Phase II Phase III* Next Key Milestone Partners + Regions Cadisegliatin (TTP399) GK Activator Type 1 Diabetes Topline Ph 3 data Partnership with G42 Healthcare to advance cadisegliatin as an adjunct therapy to i
Slide 6: Cadisegliatin: Potential to be First Oral Adjunct Therapy for T1D
6 Cadisegliatin: Potential to be First Oral Adjunct Therapy for T1D Novel oral liver selective glucokinase activator in development to reduce hypoglycemia and improve glycemic control vs. insulin alone 1: Akturk HK, et al., T1D Exchange Quality Improvement Collaborative; Factors Associated With Impr
Slide 7: The Challenge: Lowering Blood Glucose to Target While Preventing Hypoglycemia
7 The Challenge: Lowering Blood Glucose to Target While Preventing Hypoglycemia ~80% fail to achieve ADA HbA1c target of <7.0%1 1: Akturk HK, et al., T1D Exchange Quality Improvement Collaborative; Factors Associated With Improved A1C Among Adults With Type 1 Diabetes in the United States. Clin Diab
Slide 8: High Level Business Opportunity with Expansion Potential into Type 2 Diabetes
8 Patients globally with T1D, growing 3.5% annually1 9.4 M Annual gross sales opportunity globally with T1D2 $3 - 5 B T2D global population Upside High Level Business Opportunity with Expansion Potential into Type 2 Diabetes 1: T1D Index 2: Internal company analysis - data on file Large Established
Slide 9: Cadisegliatin: Liver-Selective Glucokinase Activator
9 Cadisegliatin: Liver-Selective Glucokinase Activator Glucokinase regulates glucose metabolism in liver and pancreatic β-cells Pancreas Lowers threshold for insulin production Triggers storage of glucose as glycogen Rapid decline in blood sugar Induces Hypoglycemia Reduces elevated blood sugar; glu
Slide 10: Cadisegliatin is in Development to Overcome Limitations of Past Approaches
10 Increased hypoglycemia1 Historical Limitations Elevated lipids1 Liver toxicity1 Reduction in hypoglycemia2 GK: glucokinase GKRP: glucokinase regulatory protein; 1: Ren et al., Glucokinase as an emerging antidiabetes target and recent progress in the development of its agonists, J. of Enzyme Inhib
Slide 11: In Non-Diabetic People, the Liver Acts as a Reservoir for Glucose
11 In Non-Diabetic People, the Liver Acts as a Reservoir for Glucose with Insulin and Glucokinase being Key Gatekeepers Glucokinase When blood sugar is high Glucokinase, in presence of insulin, converts some glucose into glycogen for storage Insulin Glucose When blood sugar is low Glycogen reserves
Slide 12: With Type 1 Diabetes, Glucokinase Activity Is Impaired
12 With Type 1 Diabetes and Only Low Levels of Insulin Reaching the Liver, Glucokinase Activity Is Impaired Glucokinase When blood sugar is high Glucokinase activity is diminished due to low insulin in the liver, reducing glycogen storage When blood sugar is low Insufficient glycogen reserves to mai
Slide 13: Cadisegliatin Reactivates Innate Glucose-Regulating Capacity of the Liver
13 Cadisegliatin, as a Glucokinase Activator, Reactivates Innate Glucose- Regulating Capacity of the Liver Even in the Absence of Increased Insulin Levels When blood sugar is high Glucokinase is activated despite lower insulin levels When blood sugar is low Glycogen reserves available to prevent hyp
Slide 14: Proof-of-Concept Data for Cadisegliatin in T1D and T2D
14 SimpliciT1 Phase 2 Study in T1D1 Insulin Withdrawal Study in T1D1 AGATA Phase 2 Study in T2D2 No increased risk of ketoacidosis vs. insulin alone Despite short treatment for only 7-10 days: • Improved fasting plasma glucose levels • Fewer hypoglycemic events 50% fewer symptomatic hypoglycemic epi
Slide 15: SimpliciT1 Phase 2 Trial in patients with T1D
15 Randomized, Double-Blind, Placebo Controlled 2-Part Study of ~100 patients. A total of 49 patients in the treatment groups received 800mg daily of cadisegliatin. Fewer Hypoglycemic Events Cadisegliatin Significantly Reduced Hypoglycemia and HbA1c v. Insulin Alone1 SimpliciT1 Phase 2 Trial in pati
Slide 16: No Observed Increased Risk of Ketoacidosis vs. Insulin Alone
16 No Observed Increased Risk of Ketoacidosis with Cadisegliatin vs. Insulin Alone1 SimpliciT1 Phase 2 Trial in patients with T1D Abnormal Ketones > 0.4 mmol/L Abnormal Ketones > 0.6 mmol/L 1: Klein KR et al. The SimpliciT1 study: a randomized, double-blind, placebo-controlled phase 1b/2 adaptive st
Slide 17: Cadisegliatin was Well-Tolerated Across People Living with T1D or T2D
17 Cadisegliatin was Well-Tolerated Across People Living with T1D or T2D1,2 1: Vella A, et al. Targeting hepatic glucokinase to treat diabetes with TTP399, a hepatoselective glucokinase activator. Science translational medicine. 2019 Jan 16;11(475):eaau3441. 2: Klein KR et al. The SimpliciT1 study:
Slide 18: Cadisegliatin Did Not Adversely Impact Lipids, Cholesterol or Liver Enzymes
18 Cadisegliatin Did Not Adversely Impact Lipids, Cholesterol or Liver Enzymes1 Phase 2 trial, 6-months 1: Vella A, et al. Targeting hepatic glucokinase to treat diabetes with TTP399, a hepatoselective glucokinase activator. Science translational medicine. 2019 Jan 16;11(475):eaau3441 Fasting Lipid
Slide 19: CATT1 Phase 3 Study Design
19 CATT1 Study Target Enrollment: 150 subjects at ~20 US sites Cadisegliatin CATT1 Study – Informed by FDA Advice and Published Guidance for Endpoint Selection, Exposure and Population Criteria CATT1 (TTP399-302) is the first Phase 3 trial to assess the efficacy of cadisegliatin in patients utilizin
Slide 20: Strong IP Protection for Cadisegliatin in T1D and T2D through 2041
20 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2040 2041 Issued Pending Strong IP Protection for Cadisegliatin in T1D and T2D through 2041 Exclusivity Period* * Dates are provided for informational purposes only; actual results may differ from expectations. I
Slide 21: Small Molecule Portfolio
UWTVU Small Molecule Portfolio
Slide 22: Broader Portfolio Continues to Offer Additional Upside and Shareholder Value
22 Product Indication Pre-clinical Phase I Phase II Phase III Partners + Rights PDE4 Inhibitor HPP737 Psoriasis COPD Atopic Dermatitis RAGE Antagonist Azeliragon Glioblastoma Pancreatic Cancer Breast Cancer Pneumonia Oral GLP-1R Agonist TTP273 Type 2 Diabetes Nrf2/Bach1 Modulator HPP971 /HPP3033 Oxi
Slide 23: Partnerships Provide Potential Independent Revenue Streams
23 Cadisegliatin (TTP399) GK Activator HPP737 PDE4 Inhibitor Azeliragon RAGE Antagonist Type 2 Diabetes Phase 2 initiation 2025 Middle East Psoriasis*, COPD, Atopic Dermatitis Ongoing Phase 2 and Phase 3* trials China Pneumonia**, Glioblastoma, Breast Cancer, Pancreatic Cancer Ongoing Phase 2 and Ph
Slide 24: HPP737: Oral, Novel, Potent and Selective PDE4 Inhibitor
24 HPP737: Oral, Novel, Potent and Selective PDE4 Inhibitor 1. Internal Study Report provided by Newsoara – data on file; 2: vTv Internal Studies - Data on File; 3. Internal Studies – Data on File Phase 3 in psoriasis in China completed with once daily dosing 1 Ongoing long-term open label extension
Slide 25: Azeliragon: Novel, Oral Full Spectrum RAGE Antagonist
25 Azeliragon: Novel, Oral Full Spectrum RAGE Antagonist Cantex has an exclusive global license to develop and commercialize azeliragon 1: https://cantex.com/pipeline/ 2: https://cantex.com/2024/12/09/cantex-pharmaceuticals-receives-fda-orphan-drug-designation-for-azeliragon-for-the-treatment-of-bra
Slide 26: Additional Programs: Differentiation in Large Market Opportunities
26 TTP273 Oral GLP-1 agonist HPP971 /HPP3033 Nrf2/Bach1 Modulator Obesity Phase 2 ready Oxidative inflammation Phase 1 assets Negligible observed GI side effects1 Franchise opportunity Potential for improved tolerability, convenience and accessibility vs. current standards of care1 Diverse compounds
Slide 27: TTP273: Oral Small Molecule GLP-1 Receptor Agonist
27 TTP273: Oral Small Molecule GLP-1 Receptor Agonist 1: https://www.niddk.nih.gov/health-information/health-statistics/overweight-obesity; 2: Blue Health Intelligence, Real World Trends in GLP-1 Treatment Persistence and Prescribing for Weight Management, May 2024; 3: Heather P. Whitley, Jennifer M
Slide 28: HPP971/HPP3033: Nrf2-Bach Modulator Platform
28 HPP971 /HPP3033: Nrf2-Bach 1 Modulator Platform Potential to advance multiple distinct compounds targeting reduced oxidative stress and inflammation 1: Internal studies - data on file Multiple non-electrophilic small-molecule compounds with distinct profiles Opportunity to advance multiple molecu
Slide 29: Summary: Cadisegliatin has Potential to be First Oral Adjunct Therapy for T1D
29 Summary: Cadisegliatin has Potential to be First Oral Adjunct Therapy for T1D Novel oral liver selective glucokinase activator in development to reduce hypoglycemia and improve glycemic control vs. insulin alone 1: Akturk HK, et al., T1D Exchange Quality Improvement Collaborative; Factors Associa
Slide 30: Thank You
30 Nasdaq: VTVT Thank You
vTv Therapeutics — Investor Presentation (January 2025) on 6ix