Vtv Therapeutics Inc. · NASDAQ:VTVT
Vtv Therapeutics — Investor Presentation (January 2023)
25 slides from Vtv Therapeutics's investor presentation, Jan 6, 2023
Slide 1: Improving the Lives of Millions of Patients with Type 1 Diabetes
NASDAQ: VTVT Improving the Lives of Millions of Patients with Type 1 Diabetes Non - Confidential vTv Therapeutics
Slide 2: Forward-looking statements
THE STATEMENTS MADE IN THIS PRESENTATION MAY INCLUDE FORWARD - LOOKING STATEMENTS REGARDING (I) DIABETES MARKET AND OTHER MARKETS, (II) THE DEVELOPMENT, CLINICAL TRIAL PROCESS, REGULATORY APPROVAL PROCESS AND ATTRIBUTES OF INVESTIGATIONAL AND MARKETED PRODUCTS TO TREAT THESE DISEASES AND OTHER CONDI
Slide 3: vTv has Developed a Breakthrough Oral Therapeutic for Type 1 Diabetes
vTv has Developed a Breakthrough Oral Therapeutic for Type 1 Diabetes Over 8M patients worldwide have no oral therapies to aid in the complex, lifelong challenge of managing Type 1 Diabetes (T 1 D) . vTv’s TTP 399 is a Phase 3 - ready drug intended to work in concert with insulin to reduce dangerous
Slide 4: New Leadership Builds upon Decades of Scientific & Clinical Expertise
* Scientific & clinical team has an average tenure of >15 years with vTv New Leadership Builds upon Decades of Scientific & Clinical Expertise Carmen Valcarce, PhD * Chief Scientific Officer Paul Sekhri President & CEO Rich Nelson Head of Corp Dev Border denotes new addition in last 18 months Steven
Slide 5: Distinguished SAB Continues to Support Development of TTP399
Distinguished SAB Continues to Support Development of TTP399 John Buse, MD, PhD Verne S. Caviness Distinguished Professor Director, Diabetes Center Director, NC Translational & Clinical Sciences Institute G. Alexander “Zan” Fleming, MD Founder & Executive Chairman, Kinexum Former FDA Supervisory Phy
Slide 6: Living with T1D is Like Driving Too Fast on a Dangerous Road
Living with T1D is Like Driving Too Fast on a Dangerous Road TOO MUCH INSULIN ~80% of patients fail to achieve good blood glucose control. Fear of hypoglycemia is so intense that many accept high blood glucose, risking long - term health consequences and diabetic ketoacidosis (DKA). TOO LITTLE INSUL
Slide 7: More People in the U.S. are Living with T1D than Diagnosed Annually with Major Cancers
More People in the U.S. are Living with T1D than are Diagnosed Annually with Breast, Prostate and Lung Cancer Combined Breast Prostate Lung TOTAL T1D 795,790 7 Non - Confidential vTv Therapeutics 236,740 268,490 290,560 20% of Patients are Under 20 Years Old 1,450,000 U.S. Estimated New Cancer Cases
Slide 8: TTP399: A First-Ever Oral Therapeutic for Type 1 Diabetes
TTP399 : A First - Ever Oral Therapeutic for T yp e 1 Diabetes 8 Non - Confidential vTv Therapeutics A Liver - Selective Glucokinase Activator that: 1) Reduces the Risk of Hypoglycemia 2) Improves Glycemic Control
Slide 9: In Healthy Patients, the Liver Acts as a Reservoir for Glucose
In Healthy Patients, the Liver Acts as a Reservoir for Glucose Glucokinase When blood sugar is high Glucokinase, in presence of insulin, converts some glucose into glycogen for storage Insulin Glucose 9 Non - Confidential vTv Therapeutics When blood sugar is low Glycogen reserves are broken down int
Slide 10: With Type 1 Diabetes, Glucokinase Activity in the Liver is Impaired
With Type 1 Diabetes, Glucokinase Activity in the Liver 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 maintain glucose homeostasis Hypoglycemia P
Slide 11: TTP399 Reactivates Innate Glucose-Regulating Capacity of the Liver
TTP399 Reactivates Innate Glucose - Regulating Capacity of the Liver TTP399 Glucokinase When blood sugar is high Glucokinase is activated despite lower insulin levels 11 Non - Confidential vTv Therapeutics When blood sugar is low Glycogen reserves available to prevent hypoglycemia Portal Vein
Slide 12: TTP399 is the First Liver-Selective Glucokinase Activator to Reach Phase 3
TTP399 is the First Liver - Selective Glucokinase Activator to Reach Phase 3 Pancreas Effect Lowers threshold for insulin production Triggers storage of glucose as glycogen Result Rapid decline in blood sugar levels: Induces Hypoglycemia Reduces elevated blood sugar levels; Glucose released when nee
Slide 13: Our Phase II Trial Demonstrated Statistically & Clinically Significant Efficacy & Safety
Our Phase II Trial Demonstrated Statistically & Clinically Significant Efficacy & Safety Fewer Hypoglycemic Events Improved Glycemic Control Trials sponsored in part by: 13 Non - Confidential vTv Therapeutics Randomized, Double - Blind, Placebo Controlled 2 - Part Study of ~100 patients. A total of
Slide 14: We Have the Opportunity to Ease the Burden of Managing T1D
We Have the Opportunity to Ease the Burden of Managing T1D and Improve the Lives of Patients Living with Type 1 Diabetes 14 Non - Confidential vTv Therapeutics
Slide 15: Strong IP Protection through 2039
Strong IP Protection through 2039 Patent Family No Exclusivity Period 801 805 806 808 807 809 814 803 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2040 2041 US 7,851,636 - CoM (Expires 1 - 06 - 2025) [Patent Term Extension up to 5 Years] Issued Proposed Produc
Slide 16: Breakthrough Drugs: Much Higher Odds of Approval
Breakthrough Drugs: Much Higher Odds of Approval Sources: FDA.gov; Pharma Intelligence (Q2 2021) (2011 - 2020) (2012 - 2021) “Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical
Slide 17: Phase 3 Pivotal Studies in US and EU; CRO Selected
Phase 3 Pivotal Studies in US and EU; CRO Selected Pivotal Study 1 - Type 1 Diabetes (US & EU, Primary Endpoint at 6 Months) 200 placebo 200 400mg TTP399, 2X Daily 200 800mg TTP399, 1X Daily 200 800mg TTP399, 2X Daily 12 Month Study; All patients with Continuous Glucose Monitors ENDPOINTS Primary: F
Slide 18: NDA Submission Expected by 1H 2025
NDA Submission Expected by 1H 2025 Q4 2022 Q1 2023 Phase 3 Protocols Finalized by SAB FDA Review Trial Recruitment 6 months 12 months Active Trial Phase Q3 2023 Q3 2024 NDA Preparation 5 months Q1 2025 18 Non - Confidential vTv Therapeutics NDA Submission & FDA Review 6 - 12 months EU EMA submission
Slide 19: Additional Pipeline Creates Further Upside
Additional Pipeline Creates Further Upside vTv Partner PRODUCT PRE - CLINICAL PHASE I PHASE II PHASE III PARTERS + REGIONS TTP399 GK Activator Type 1 Diabetes Type 2 Diabetes TTP273 Oral GLP - 1R Agonist Cystic Fibrosis - Related Diabetes Type II Diabetes Asia (excl. Japan) HPP737 SAD/MAD Completed
Slide 20: Investors, Partners, and Board
Investors, Partners, and Board Paul Sekhri President & CEO John Fry Director Hersh Kozlov Director Fahed Al Marzooqi, MD Director Jon Isaacsohn, MD Chairman Chandresh Harjivan, MD Director Keith Harris, PhD Director Howard Weiner, MD Director Rich Nelson EVP Corp. Dev. Current Board: Majority stakeh
Slide 21: Appendix
Appendix Non - Confidential vTv Therapeutics
Slide 22: Safety: TTP399 Tested in Clinical Trials with Over 560 Subjects Dosed
Safety: TTP399 T e s t e d in 13 Clinical Trials with Over 560 Subjects Dosed 11 Clinical Studies in Healthy Volunteers & Type 2 Diabetes Patients 9 Phase 1 Studies 2 Phase 2 Studies 2 Clinical Studies in Type 1 Diabetes Patients Simplici - T1 Study Sentinel Phase – 5 Patients Part 1 – 19 Patients P
Slide 23: Safety: Cumulative Incidence of Subjects with Abnormal Ketones
Safety: Cumulative Incidence of Subjects with Abnormal Ketones BOHB > 0.4 and 0.6 mmol/L as Determined by Central Lab Central Lab Ketone Values > 0.4 mmol/L Central Lab Ketone Values > 0.6 mmol/L Study Details: https://diabetesjournals.org/care/article/44/4/960/138590/The - SimpliciT1 - Study - A -
Slide 24: Safety: Mechanistic Study of DKA Risk from TTP399
Safety: Mechanistic Study of DKA Risk from TTP399 Objective: Evaluate Effects of TTP399 on Ketogenesis During Insulinopenia Study Design Participants: 23 adults with T1D on insulin pumps Dosing: TTP399 800mg or placebo once daily for 7 days (randomized 1:1) Insulin withdrawal test : on day 7, insuli
Slide 25: Safety: No Observed Risk of Euglycemic DKA During Insulin Deficiency
Safety: No Observed Risk of Euglycemic DKA During Conditions of Insulin Deficiency (IWT) Klein et at. Diabetes Obesity and Metabolism June 2022. https://doi.org/10.1111/dom.14697 25 Non - Confidential vTv Therapeutics
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