Viking Therapeutics, Inc. · NASDAQ:VKTX
Viking Therapeutics — Investor Presentation (April 2014)
34 slides from Viking Therapeutics's investor presentation, April 2014
Slide 1: Corporate presentation April 2014
Corporate presentation April 2014
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains statements about our future expectations, plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from
Slide 3: Investment Highlights
Investment Highlights • First-in-class program for type 2 diabetes, VK0612 • Novel small molecule gluconeogenesis inhibitor • Clinical POC completed; phase IIb planned • Differentiated commercial profile; potentially superior efficacy, excellent preliminary safety • Attractive market positioning, op
Slide 4: Diabetes, A Growing Healthcare Challenge
Diabetes, A Growing Healthcare Challenge 25.8M U.S. Cases Prevalence of Diabetes, U.S. Adults • 18.8M diagnosed 1995 2010 • 7.0M undiagnosed • >90% Type 2 Economic impact • $245B in healthcare Prevalence <4.5% <4.5% 4.5 – 5.9% 6.0 – 7.4% costs in 2012 7.5 - 8.9% >9% Long-term complications: renal fa
Slide 5: Robust Appetite for New Therapies
Robust Appetite for New Therapies • Market size suggests multiple blockbusters possible, as with hypertension, statins • Demand for new mechanisms despite existing options • Recent launches have enjoyed rapid adoption even with modest antiglycemic effects; e.g. DPP-4 inhibitors Drug 2007 2008 2009 2
Slide 6: Existing Landscape Presents Opportunities
Existing Landscape Presents Opportunities • Strengths: Current Landscape • Weight neutral (metformin, DPP-4, SGLT inhibitors) • Improved side effect profiles vs. older therapies • Weaknesses: Current Landscape • Generally modest efficacy; HbA1c d -0.6% to -0.8% • Questionable durability, long-term s
Slide 7: VK0612 Market Potential: Base Case >5M Patients
VK0612 Market Potential: Base Case >5M Patients 18.8M patients - 58% on OAD - 14% OAD + injectible ~11 Years From Diagnosis - 12% Insulin only - 16% No medication Diet and 10.9M patients 2.6M patients 1.7M Annual Diagnoses CDC 2011 Diabetes Fact Sheet Exercise 1st-Line 2nd-Line 3rd-Line 4th-Line 5th
Slide 8: Targets for Therapeutic Intervention
Targets for Therapeutic Intervention Liver targeted by: VK0612, metformin; No other approved Tx Pancreas targeted by: DPP-4s, SU, GLP-1 8
Slide 9: Hepatic Gluconeogenesis
Hepatic Gluconeogenesis Attractive pathway for diabetes therapy Hepatic Glucose Production (HGP) Contributions to HGP Glycogenolysis + Gluconeogensis = HGP • GNG Elevated in type 2 diabetes • Major source of glucose output • Contributes ~70% of FPG 9 Viking References: 1) J.Clin.Invest. 90, 1323-132
Slide 10: Fructose-1,6-Bisphosphatase, FBPase
Fructose-1,6-Bisphosphatase, FBPase Glycolysis Gluconeogenesis Glucose • Target of VK0612 Hexokinase/Glucokinase Glucose-6-phosphatase • Low nM inhibitor Glucose-6-Phosphate • Plays critical role in GNG Fructose-1,6-Bisphosphatase Phosphofructokinase (FBPase) • Increased activity in T2D Fructose-1,6
Slide 11: Known Genetic Deficiency Provides Insight
Known Genetic Deficiency Provides Insight • Baker-Winegrad Disease, 1970 • Patients lack functional fructose-1,6-bisphosphatase • Effectively a human knock-out model • Once diagnosed, controlled through diet and behavior; patients otherwise healthy with normal lifespan • Suggests attractive target f
Slide 12: Our Lead Program: VK0612
Our Lead Program: VK0612 • Selective 31nM inhibitor of fructose-1,6-bisphosphatase • Successful phase IIa study: Highly clinically and statistically significant effects on plasma glucose • Safe, well-tolerated • PK, formulation conducive to QD dosing • Differentiated mechanism, facilitates combinati
Slide 13: VK0612: Clinical Overview
VK0612: Clinical Overview • Five Phase I studies completed • Evaluated safety/tolerability and PK • Single doses of up to 1000 mg • Multiple doses of up to 400 mg QD for 14 days • Promising safety, tolerability (>300 patients) • No hypoglycemia, no lacticemia • GI events similar across treatment gro
Slide 14: VK0612: 28-Day Phase IIa Highlights
VK0612: 28-Day Phase IIa Highlights • Five arm, dose-ranging study, QD dosing (n=100) • Day 28 vs. Baseline ΔFPG (mg/dL): Statistically and clinically significant glucose lowering Patients ΔFPG PBO-adjusted ΔFPG Cohort N Baseline FPG * Mean 95% CI Mean 95% CI Placebo 23 185.0 (41.7) 8.2 (-8.4, 24.7)
Slide 15: VK0612: Phase IIa Data, Advanced Patients
VK0612: Phase IIa Data, Advanced Patients Patients with baseline FPG > 180 mg/dL Patients ΔFPG PBO-adjusted ΔFPG Cohort N Baseline FPG * Mean 95% CI Mean 95% CI Placebo 12 216.3 (30.0) 15.2 (-12.6, 43.0) ----- ----- 10 mg 6 215.5 (40.3) 18.2 (-21.2, 57.5) 3 (-45.1, 51.1) 50 mg 8 218.4 (19.3) -2.6 (-
Slide 16: VK0612: 14-Day Phase Ib Highlights
VK0612: 14-Day Phase Ib Highlights • Four arm, placebo-controlled, BID dosing (n=42) • Important enrollment criterion: FPG > 180mg/dL • Results: Clinically, statistically significant effect on FPG • 200mg, 400mg BID: Potential HbA1c effect -1% to -1.5% Patients Day 15 ΔFPG PBO-adjusted ΔFPG Cohort N
Slide 17: VK0612: Phase Ib Safety, Tolerability Data
VK0612: Phase Ib Safety, Tolerability Data Safety Takeaways • Safe at all doses; No drug-related SAEs • Dose-limiting nausea, vomiting at 400mg BID • Well-tolerated at 200mg BID • No hypoglycemia • No lactic acidosis • No discontinuations due to lab abnormalities 17 Viking
Slide 18: VK0612: Development Summary
VK0612: Development Summary Human POC successfully demonstrated • Glucose-lowering observed throughout the day • Preliminary FPG data: Outstanding HbA1c potential • Weight-neutral, lipid-neutral • Safe and well-tolerated • MTD, dose-limiting tolerability identified • >300 patients in database; no dr
Slide 19: VK0612: Attractive Competitive Profile
VK0612: Attractive Competitive Profile Drug Target DFPG DHbA1c DWeight Safety, Tolerability, Other mg/dL (wks)1 % (wks) VK0612 FBPase -502 to -583 Expect -1.0 Neutral Dose limiting nausea at >2x (2 to 4) or greater potential commercial doses Sitagliptin DPP4 -20 (12) -0.6 (12) Neutral Modest efficac
Slide 20: VK0612 vs. Existing Landscape
VK0612 vs. Existing Landscape Commercial profile compares favorably to existing agents • Efficacy, safety, durability, convenience, mechanism VK0612 Metformin Sulfonylurea TZD DPP-4 SGLT2 Glycemic impact Durability Safety, preclinical Safety, clinical Safety, long-term NA Tolerability Weight neutral
Slide 21: What do endocrinologists think?
What do endocrinologists think? Market research: Significant opportunity in multiple settings Example, poorly-controlled patients: Q: Suppose the therapy above demonstrated efficacy in patients no longer receiving benefit from a metformin-containing regimen. Would you replace metformin with the new
Slide 22: VK0612: Efficacy in Metformin-Experienced
VK0612: Efficacy in Metformin-Experienced Phase Ib: Patients receiving metformin at screening visit Mean FPG Placebo-adjusted at screening Mean FPG, Day 14 DFPG vs. Day 14 DFPG vs. 1 2 Cohort N (mg/dL) Day 14 Screening visit Screening visit Placebo 9 172 236 65 - 200mg 8 183 151 -32 -97 400mg 7 170
Slide 23: FBPase: Extensive Prior Validation
FBPase: Extensive Prior Validation • Historically attractive but difficult to approach • PFE, ABT, Roche, NVO, others • Challenges: potency, selectivity, PK • Daiichi-Sankyo/Metabasis; Most successful • Discovered novel class of potent, selective, pharmaceutically relevant small molecule inhibitors
Slide 24: Daiichi-Metabasis CS-917, Clinical Summary
Daiichi-Metabasis CS-917, Clinical Summary Phase II Overview • 14 and 28 day studies demonstrated human POC • Statistically significant anti-glycemic effects Phase IIb Highlights: 12 week BID dosing, 400 patients • Sub-optimal (low) dose, mild patient population = low chance of success • Trial faile
Slide 25: Daiichi-Metabasis CS-917: Takeaways
Daiichi-Metabasis CS-917: Takeaways Clinical Experience Validates FBPase Target for T2D • Best efficacy in poorly controlled patients; baseline FPG > 180mg/dL Placebo 50 BID 100 BID 200 BID Metformin 4 Week Phase 2a Trial, All Patients (Study 202) N= 35 37 36 D FPG at 4 weeks, all patients (mg/dL) +
Slide 26: VK0612 vs. CS-917, Issues and Implications
VK0612 vs. CS-917, Issues and Implications Gluconeogenesis Glucose 1st Generation 2nd Generation CS-917 VK0612 Inhibits FBPase, Inhibits FBPase, reducing glucose reducing glucose output output Human Not metabolized by NAT1, NAT2 NAT1, NAT2. Gluconeogenesis Substrate Pool Avoids metabolites that coul
Slide 27: VK0612 vs. CS-917 Comparative Profile
VK0612 vs. CS-917 Comparative Profile Key differences: VK0612 vs CS-917 CS-917 metabolite (black), VK0612 metabolite (black), • Resistant to metabolic inactivation active drug (red) active drug (red) • Not toxic to mitochondria • Increased oral bioavailability • ~5x higher plasma levels • Longer T½
Slide 28: VK0612: Development Plans
VK0612: Development Plans • Conduct phase IIb trial • Multi-arm dose ranging • 12-Week study to assess HbA1c • Metformin comparator (not powered for superiority) • Conduct parallel exploratory phase I trials • Metformin combination • Renally impaired population • Data possible 2H15 28 Viking
Slide 29: VK0612: Development Timelines, Costs
VK0612: Development Timelines, Costs Development Timeline 2014 2015 2016 2017 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase 2b, approximately $14M DDI, renal insufficiency trials, approximately $4M CMC, non-clinical toxicology, approximately $5M Estimated external costs to phase III: $23M -
Slide 30: Summary of Potential Phase III and CV Plans
Summary of Potential Phase III and CV Plans • FDA diabetes requirements: >2500 exposures, >1,300 for 1 year, >300 for 18 months • CV safety analysis from >1,300 patients; focus on 95% Confidence Interval around Hazard Ratio, relative risks • If upper bounds of HR CI >1.8, pre-market CV study • If up
Slide 31: Licensing Terms, Intellectual Property
Licensing Terms, Intellectual Property • $1M Up-front to Ligand • $38M Clinical and regulatory milestones • Includes $33M post-phase III • No commercial/sales milestones • $10M Each for EU, Japan approvals • Tiered royalties to low double-digit • Composition of matter to 2025 • Additional filings pl
Slide 32: Management
Management Nimble model minimizes expenses, accelerates decisions CEO: Brian Lian, Ph.D. SunTrust, CIBC World Markets, Amgen CMO: Rochelle Hanley, MD, FACP GSK, QuatRx, Pfizer, Parke-Davis, Duke University COO: Misha Dinerman, MD Piper Jaffray, CIBC World Markets SVP, Drug Development: Joseph Lambin
Slide 33: Consultants and Advisors
Consultants and Advisors • David Bullough, Ph.D. VP, Preclinical Development, RaNA. Former Executive Director, Metabolic Diseases, Pfizer. Former VP and Head of Pharmaceutical and Preclinical Development, Metabasis Therapeutics. • Alan D. Cherrington, Ph.D. Professor of Molecular Physiology and Biop
Slide 34: Viking Therapeutics, Summary
Viking Therapeutics, Summary • Lead program VK0612: Novel, first-in-class drug candidate for type 2 diabetes • Differentiated mechanism with competitive advantages • Excellent clinical POC data suggest potency, safety, combinability, attractive commercial profile • Phase IIb, metformin, renal insuff
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