Inhibikase Therapeutics, Inc. · NASDAQ:IKT
Inhibikase Therapeutics — Investor Presentation (February 2021)
21 slides from Inhibikase Therapeutics's investor presentation, Feb 8, 2021
Slide 1: Therapies in Clinical Development to Reverse Neurodegeneration in Parkinson's Disease
Therapies in Clinical Development to Reverse the Progression of Neurodegeneration in Parkinson’s Disease 1Q 2021 I NVESTOR PRESENTATION IKT
Slide 2: Forward-looking statements disclaimer
2 2 This presentation shall not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the s
Slide 3: Company Highlights: Driving Functional Reversal of Parkinson's Disease
COMPANY HIGHLIGHTS Driving Functional Reversal of Parkinson’s Disease ▪ Multi - therapeutic pipeline with emphasis on neurodegeneration ▪ Lead programs developing drugs targeting a gateway along a common pathway that initiates Parkinson’s Disease (PD) inside and outside of the brain ▪ IkT - 148009 s
Slide 4: Additional Therapies in the Pipeline
ADDITIONAL THERAPIES IN THE PIPELINE Multi - Indication Pipeline in Neurodegeneration, Oncology and Infectious Disease CLINICAL DEVELOPMENT 1 BIOMARKER Drug Target Drug candidate Modality Disease indication PRECLINICAL DEVELOPMENT PHASE 1 PHASE 2 PHASE 3 Preclinical target engagement 1 Clinical targ
Slide 5: Large Market, Opportunity For Disease Modification
Large Market, Opportunity For Disease Modification AVERAGE AGE OF ONSET 60,000 NEW CASES / YR Comorbidities ARTHRITIS HEART / CIRCULATORY PSYCHOSIS DEMENTIA 47% 36% 35% 30% Prevalence 700,000 – 1,000,000 38,000 DEATHS / YEAR Mortality 1/3 of a Patient’s Lifespan 60 1.5x – 2x Men are more likely to b
Slide 6: Clarification of Causation in Parkinson's Reveals c-Abl as a Primary Culprit
NEURODEGENERATION Clarification of Causation in Parkinson’s Reveals c - Abl as a Primary Culprit ▪ Parkinson’s Disease (PD) is a neurodegenerative disease which limits function of nerve cells throughout the brain and gut. ▪ PD conditions include: Tremors Slowed Movement Impaired Balance Permanent Co
Slide 7: The Path to Neurodegeneration
THE PATH TO NEURODENERATION Stressors Trigger the Production of α - Synuclein Plaques Which Are Chemically Modified Into a Toxic Form Leading to Neurodegeneration Stressors 1 Trigger the Production of α - Synuclein α - Synuclein Forms Fibrous Aggregates we call Plaques Oxidative / nitrosative stress
Slide 8: Inhibikase's Proof: Activated c-Abl Is the Gateway in the Disease Path
INHIBIKASE’S PROOF ACTIVATED C - ABL IS THE GATEWAY IN THE DISEASE PATH α - Synuclein Plaques Do Not Cause Disease Without c - Abl Modification in Humanized Preclinical Models 1 α - Synuclein plaque in the ABSENCE OF c - Abl CAUSES NO NEURODEGENERATION AFTER 6 MONTHS 1 Brain 142:2380ff (2019) Contro
Slide 9: Pathologic c-Abl-Modified α-Synuclein Is Present in Parkinson's Patient Brain
STUDY Pathologic, c - Abl - Modified α - Synuclein (pY39) is Present in Parkinson’s Patient Brain 1 Toxic pY39 - a - Synuclein Abundant In Substantia Nigra (SN) of Patients Toxic pY39 - a - Synuclein Prominent in Lewy Bodies 1 J Clin Invest. 126 , 2970 - 88 (2016) 9
Slide 10: Our Method of Action to Derail the Path to Neurodegeneration
OUR METHOD OF ACTION TO DERAIL THE PATH TO NEURODEGENERATION c - Abl Inhibition May Drive Functional Reversal The Gateway that Converts α - Synuclein into ITS TOXIC FORM CAN BE SUPPRESSED BY INHIBITING c - ABL 1. INHIBITS c - Abl at this Gateway by blocking pY39 Formation 2. PROMOTES CLEARANCE of pa
Slide 11: Low Toxicity, Brain Penetrant c-Abl Inhibitor in Clinical Development
Low Toxicity, Brain Penetrant c - Abl Inhibitor in Clinical Development ▪ No observed toxicity from off target kinase inhibition ▪ No CNS toxicity ▪ No toxicity observed even on 210+ day dosing >150 mg/kg/day ▪ Nearly complete neuroprotection in a - synuclein progressive disease models ▪ Multi - kil
Slide 12: Phases and Development Intervals
Phases and Development Intervals ONGOING TRIALS IN SAFETY AND DOSING MONTHS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Phase 1 SAD / MAD (12 Months) Phase 1 Chronic Toxicology Studies (11 Months) Single Ascending Dose (SAD) ▪ 8 dosing cohorts (25 – 400 mg, 1x/day) ▪ 8 patients/cohort, 2:1 randomiz
Slide 13: Reversal of Functional Loss Following Oral Administration of IkT-148009 in Mice
Baseline Neuromuscular Coordination Behavioral Marker Toxic Levels of Synuclein Are Introduced Into One Side of the Mouse Brain Healthy Mice Run In Circles at the Average Rate of 25 Turns : 10 Min Toxicity renders the mice trembling and only able to run in circles Treatment Started 6 Weeks After Ons
Slide 14: Oral IkT-148009 Preserves Neural Anatomy
14 Placebo IkT - 148009 only, no disease A53T induced disease A53T - induced disease + IkT - 148009 Normal # neurons Rescued # neurons ( ≥ 80%) Disease # neurons (< 50%) Therapeutic Treatment With Oral IkT - 148009 Preserves Neural Anatomy ANIMAL STUDY BASIS OF 148009 THERAPY IkT - 148009 restores f
Slide 15: Parkinson's May Begin in the Gut
Parkinson’s May Begin in the Gut Easy access Can demonstrate disease benefit with quantitative endpoints Biopsy and Biomarkers Large effect size GI disorders resulting from kinase modification of a - synuclein: Dysphagia Unresolvable constipation Gastroesophageal reflux Gastroparesis The Gut - Brain
Slide 16: Oral IkT-148009 Reverses Functional Loss in the GI Tract in Mice
α - Synuclein Aggregates Introduced Into Gut Slows Gut Transit Time METHOD OF MEASUREMENT At 3 months defecation slows to 500 min (3x normal); At 6 months defecation slows to 800 min (5x normal); Normal = 165 min POST TREATMENT RESULTS Measure defecation rate Neuron count read out by Whole Gut Trans
Slide 17: Functional Reversal of GI Defect with Clearance of Toxic α-Synuclein
IkT - 148009 nearly clears pathological α - synuclein ( green dots have been cleared ) 17 Label Toxic Synuclein Label Neurons Overlay Functional Reversal of GI Defect Occurs Concomitantly with Clearance of Toxic α - Synuclein Following Oral IkT - 148009 Treatment EVIDENCE OF FUNCTIONAL RECOVERY IN T
Slide 18: Targeting c-Abl Can Block the Path to Neurodegeneration
▪ IKT - 148009 drives functional recovery inside and outside of the brain ▪ IKT - 148009 drives clearance of the toxic form of a - synuclein ▪ IKT - 148009 evaluation in the GI offers unique paths for clinical success Targeting c - Abl Can Block the Path to Neurodegeneration 18 RESEARCH ADVANCES ARE
Slide 19: About Us: Management Team
ABOUT US Management Team with Deep Experience in Drug Development and Commercialization Milton Werner, PhD President & CEO Previously, Dr . Werner served as Director of Research at Celtaxsys . From September 1996 until June 2007 , Dr . Werner was a Head of the Laboratory of Molecular Biophysics at T
Slide 20: Board of Directors and Advisors
Board of Directors Industry - Leading Advisors Mr . Dennis Berman has been a co - founder, board member, and/or seed investor in many private biotechnology and technology companies, five of which have gone public . He currently serves as the President of Molino Ventures, LLC a board advisory and ven
Slide 21: Objectives, Upcoming Milestones and Contact Us
OBJECTIVES Pre - clinical Activities Oncology Prodrug, IkT - 001Pro: Commercial product GMP mfg. IND filing Clinical development for IkT - 148009 Elderly healthy volunteer Phase 1 Comparative chronic toxicology rat and monkey Team Build - out, Medicinal Chemistry, Pre - clinical Research, G&A Upcomi
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